FDF

Product Code: FDF


Products Classified as FDF

1768Colonoscope And Accessories, Flexible/rigidEndoscope And Accessories.

Total Product Life Cycle (TPLC) Devices

1768Colonoscope And Accessories, Flexible/rigidEndoscope And Accessories.

FDA Consensus Standards

Colonoscope And Accessories, Flexible/Rigid [32386]21 CFR §876.1500 🔎
Colonoscope And Accessories, Flexible/Rigid [30564]21 CFR §876.1500 🔎
Colonoscope And Accessories, Flexible/Rigid [30563]21 CFR §876.1500 🔎
Colonoscope And Accessories, Flexible/Rigid [33513]21 CFR §876.1500 🔎
Colonoscope And Accessories, Flexible/Rigid [36928]21 CFR §876.1500 🔎
Colonoscope And Accessories, Flexible/Rigid [31951]21 CFR §876.1500 🔎

Pre-market Notifications for FDF

K220007Pure-Vu EVS SystemMotus GI Medical Technologies Ltd.
K213773Insufflation Retention DeviceBpendo, LLC
K213578Balloon Dilatation CatheterHangzhou AGS MedTech Co., Ltd.
K211819DiLumen C2 And Tool MountLumendi, LLC
K210981Pure Vu SystemMotus GI Medical Technologies Ltd.
K210851DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC
K210052Saneso Colonoscope 360-A (Model: With/without Select Band Imaging (SBI) And With/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: With/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: With/without SelectSaneso Inc.
K202469G-EYE SystemSMART Medical Systems Ltd.
K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190IOlympus Medical Systems Corp.
K192664FUJIFILM Endoscope Model EC-760Z-V/LFUJIFILM Corporation
K192588G-EYE SystemSMART Medical Systems Ltd.
K191220Pure Vu SystemMotus GI Medical Technologies Ltd.
K190669EndoticsEra Endoscopy S.r.l.
K190649FUJIFILM Endoscope Model EC-760S-V/LFUJIFILM Corporation
K182540DiLumen Endolumenal Interventional PlatformLumendi, LLC

Global Unique Device Identification Database

00677964067174Colonoscope And Accessories, Flexible/Rigid
00677964065064Colonoscope And Accessories, Flexible/Rigid
00677964060274Colonoscope And Accessories, Flexible/Rigid
00677964055935Colonoscope And Accessories, Flexible/Rigid
00816849019666Colonoscope And Accessories, Flexible/Rigid
10816765013448Colonoscope and accessories, flexible/rigid
10816765012779Colonoscope and accessories, flexible/rigid
10816765011932Colonoscope and accessories, flexible/rigid
00817658020195Colonoscope And Accessories, Flexible/Rigid
00817658020188Colonoscope And Accessories, Flexible/Rigid
00817658020164Colonoscope And Accessories, Flexible/Rigid
00817658020157Colonoscope And Accessories, Flexible/Rigid
10865309000246Colonoscope And Accessories, Flexible/Rigid
10865309000239Colonoscope And Accessories, Flexible/Rigid
00865309000225Colonoscope And Accessories, Flexible/Rigid

Maude Adverse Events

EVIS EXERA II COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-31
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-31
CRE WIREGUIDEDBOSTON SCIENTIFIC CORPORATION2020-03-31
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-28
MU-1 100V MAINTENANCE UNIT SETOLYMPUS MEDICAL SYSTEMS CORP.2020-03-26
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-25
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-25
COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGIDOLYMPUS MEDICAL SYSTEMS CORP.2020-03-24
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-17
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-16
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-15
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-13
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-11
EVIS EXERA II COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-11
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-10
PENTAXHOYA CORPORATION PENTAX TOKYO OFFICE2020-03-10
EVIS EXERA II COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-10
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-10
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-09
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-09
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-09
EVIS EXERA II COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-09
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
PENTAXHOYA CORPORATION PENTAX TOKYO OFFICE2020-03-06
PENTAXHOYA CORPORATION PENTAX TOKYO OFFICE2020-03-06
EVIS LUCERA ELITE COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-05
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-05
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-04
EVIS EXERA II COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-04
EVIS LUCERA ELITE COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-04
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-03
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-03
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-27
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-27
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-27
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-27
EVIS LUCERA ELITE COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-26
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-25
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-25
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-25
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-25
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-25
EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-25
EVIS EXERA LLL COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-25
PENTAXHOYA CORPORATION PENTAX TOKYO OFFICE2020-02-21
PENTAXHOYA CORPORATION PENTAX TOKYO OFFICE2020-02-20

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